Objective:To observe the clinical efficacy of acupuncture combined with self-designed sputum clear heart drink in treating primary insomnia of phlegm-heat disturbing cardiotype,compared with simple acupuncture and self-designed sputum clear heart drink,in order to enrich the clinical treatment.Methods:A total of 81 patients who met the requirements of this study with primary insomnia due to phlegm-heat disturbing heart were randomly divided into the acupuncture group,the Chinese medicine group,and the acupuncture-medicine combination group,with 27 patients in each group.In the acupuncture group,the main acupoints were selected as follows: Zhaohai(bilateral),Shenmai(bilateral),Shenmen(bilateral),Sanyinjiao(bilateral),Shuibian(bilateral)and Sishencong.Fenglong(bilateral)and Laogong(bilateral)were selected as the matching acupoints.The acupoints of Shenmai,Fenglong and Laogong were treated with the purging method,while the acupoints of Zhaohai were treated with the reducing method,the other points were given by mild reinforcing and attenuating,and they were retained for30 min.The acupuncture was performed once a day,with one day’s rest for consecutive six days.Patients in the Chinese medicine group were treated with self-designed sputum clear heart drink,one dose a day(300ml),which was warmly taken before breakfast and after dinner at 150 ml,and orally taken seven doses per week.The acupuncture-medicine combination group was the combination application of the acupuncture group and the Chinese medicine group.The patients in the three groups took one week as a course of treatment,and received continuous treatment for four courses.The observation period was 8 weeks.The PSQI score,SAS score,SDS score and total score of TCM syndromes were recorded before treatment,after treatment and during follow-up after treatment.After 4 weeks of treatment,the efficacy was evaluated,and the long-term efficacy of the three groups was observed at the8 th week.SPSS26.0 statistical software was used for statistical processing of the data to analyze and compare the differences among the three groups.Results:1.General information: there were no significant difference in gender,age or course of disease among the three groups(P>0.05),indicating that they can be compared.2.After four weeks of treatment,each component factor of PSQI(sleep quality,sleep latency,sleep time,sleep efficiency,sleep disturbance and daytime dysfunction),total PSQI score,SAS score,SDS score and total TCM syndrome score in the three groups were decreased.The differences in scores of patients receiving different treatment times among the three groups were statistically significant in each group(P<0.05).By pairwise comparison of treatment times,there was statistical difference in the scores among the other treatment time points(P<0.05)except for the treating four weeks and the follow-up visit after eight week(P>0.05),which indicated that the treatments in the three groups were effective and had long-term effects.After four weeks of treatment,the scores of each component factor and the total score of PSQI,SAS score,SDS score and total score of TCM syndrome among the three groups were compared,and the differences were statistically significant(P<0.05).For the pairwise comparison between groups,the difference between the acupuncture group and the Chinese medicine group was not statistically significant(P>0.05).The results of the comparison between the acupuncture and medicine combination group and the acupuncture group as well as the comparison between the acupuncture and medicine combination group and the Chinese medicine group were statistically significant(P<0.05),indicating that the combination of acupuncture and medicine had the best therapeutic effect among the three groups.3.After the total course of treatment in the three groups,the main efficacy was evaluated according to the PSQI reduction rate : the total effective rates in the acupuncture group,Chinese medicine group and acupuncture and medicine combination group were 73.08%,76.92% and88.00%.The differences among the three groups were statistically significant(P<0.05).Pairwise comparison of the total effective rates showed statistical significance(P<0.05)except for no significant difference between the acupuncture group and the Chinese medicine group(P>0.05),indicating that the acupuncture and medicine combination group had the best effect in the treatment of primary insomnia due to phlegm-heat disturbing heart.4.After the total course of treatment in the three groups,secondary efficacy evaluation was performed according to the reducing rate of TCM syndrome: the total effective rates in the acupuncture group,Chinese medicine group and acupuncture and medicine combination group were80.77%,84.62% and 92.00%.The differences among the three groups were statistically significant(P<0.05).Pairwise comparison of the total effective rates showed statistical significance(P<0.05)except for no significant difference between the acupuncture group and the Chinese medicine group(P>0.05),indicating that the acupuncture and medicine combination group had the best effect in the treatment of primary insomnia due to phlegm-heat disturbing heart.Conclusion:1.Acupuncture,Chinese medicine and the combination of acupuncture and medicine are all effective for the treatment of primary insomnia of phlegm-heat disturbing cardiotype.2.Acupuncture combined with self-designed sputum clear heart drink can improve the symptoms of patients with primary insomnia of phlegm-heat disturbing cardiotype and Improve anxiety and depression in patients.And the effect is better than that of simple acupuncture or simple Chinese medicine.3.Acupuncture combined with self-designed sputum clear heart drink had long-term efficacy in the treatment of patients with primary insomnia of phlegm-heat disturbing cardiotype. |